Index of drugs

Symptomatic treatment of mild to moderately severe dementia in Alzheimer's disease.

1 tabl powl. contains either 5 mg or 10 mg donepezil hydrochloride (and respectively 88.10 mg or 176.20 mg lactose).

Selective and reversible acetylcholinesterase inhibitor - the main enzyme that breaks down acetylcholine in nerve endings at o.u.n. The inhibition of red cell acetylcholinesterase activity by donepezil hydrochloride correlates with changes in ADAS-cog scores - a sensitive scale that studies selected manifestations of cognitive ability. The effect of donepezil hydrochloride on changing the course of basic neurological disease has not been studied. Therefore, it can not be considered as having any effect on the progression of the disease. Maximum plasma concentrations are achieved after about 3-4 hours after administration. T_0,5 drug in the plasma is about 70 hours. A state close to stationary is reached within 3 weeks of starting treatment. The food does not affect absorption. Donepezil hydrochloride is approximately 95% bound to plasma proteins. It is excreted in unchanged form in the urine as well as metabolized by the cytochrome P450 system to numerous metabolites.

Hypersensitivity to the active substance, piperidine derivatives or to any of the excipients.

There are no studies on the use of the preparation in patients with severe dementia in Alzheimer's disease, with other types of dementia or with other types of memory disorders (eg associated with aging processes). The preparation may increase the effect of muscle relaxants, from the group of succinylcholine, used for general anesthesia. Cholinesterase inhibitors may have a vagotaxic effect on heart rate (eg, cause bradycardia) - this may be particularly important in patients with a sick sinus syndrome or with supraventricular conduction disorders (eg with sinoatrial or atrioventricular block). Fainting and convulsive seizures have been reported. Patients should be assessed for cardiac block or long sinus inhibitions during the study. In patients with an increased risk of developing ulcers, eg with a history of peptic ulcer disease or those taking NSAIDs simultaneously, the occurrence of appropriate symptoms should be monitored. Cholinomimetics may cause obstruction of urine outflow from the bladder, however, no such effects have been observed in clinical trials of donepezil hydrochloride. Cholinomimetics may exacerbate or induce extrapyramidal symptoms. Caution should be exercised in patients with a history of asthma or obstructive pulmonary disease. Co-administration with other acetylcholinesterase inhibitors, agonists or cholinergic antagonists should be avoided. The preparation contains lactose - should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lappa type) or with malabsorption of glucose-galactose.

The drug should not be used during pregnancy unless clearly necessary. Women taking donepezil hydrochloride should not breast-feed.

Very common: diarrhea, nausea, headache. Common: colds, anorexia, hallucinations, agitation, aggressive behavior, fainting, dizziness, insomnia, vomiting, abdominal disorder, rash, pruritus, muscle cramps, urinary incontinence, fatigue, pain, accidents. Uncommon: convulsions, bradycardia, gastrointestinal bleeding, gastric and duodenal ulcers, slight increase in serum CK. Rare: extrapyramidal symptoms, sinoatrial block, atrioventricular block, liver dysfunction (including hepatitis). Very rare: a neuroleptic malignant syndrome. When testing patients for nausea or seizures, the possibility of a cardiac block or long sinus inhibitions should be considered. Hallucinations, agitation and aggressive behavior subsided after dose reduction or discontinuation of the drug. In cases of unexplained liver dysfunction, discontinuation of the drug should be considered.

Orally.Adults (including elderly): treatment starts with a 5 mg dose once a day, in the evening, just before bedtime. Administration of a 5 mg daily dose should continue for at least 1 month, allowing a clinical assessment of the effectiveness of the treatment and achieving a steady state of donepezil hydrochloride. After a clinical review of the treatment for one month at a dose of 5 mg per day, the dose may be increased to 10 mg once a day. The maximum recommended daily dose is 10 mg.Special groups of patients. A similar dosing regimen may be used in patients with renal insufficiency. In patients with mild or moderate hepatic impairment, the dose should be titrated according to individual patient tolerability. There are no data on the use of the drug in patients with severe hepatic impairment. The drug is not recommended for use in children and adolescents.Way of giving.Treatment with the product should be started and supervised by a doctor who has experience in the diagnosis and treatment of dementia in Alzheimer's disease. The diagnosis should be made in accordance with the approved guidelines (eg DSM IV, ICD 10). Treatment with donepezil hydrochloride can only be started if the patient can be monitored continuously. Maintenance treatment should be continued for as long as the beneficial effects of the medicine remain. The assessment of the therapeutic benefits of donepezil hydrochloride should be done regularly. You should consider discontinuing the medicine when there is no longer any curative effect. The individual response of the patient to donepezil hydrochloride can not be predicted. After discontinuation of treatment, a gradual decrease in the beneficial effects of treatment with the preparation was observed.